NCT03081806

A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis Knee Pain

A Phase 3, Multicenter, Randomized, Placebo-controlled, Double-blind, 22-Week and 30-Week Open-label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of X0002 Spray in Relief of the Pain for Subjects With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Techfields Pharma Co. Ltd · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 3, Multicenter, 22-Week, double-blind and 30-Week open label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of pain of subjects with Osteoarthritis of the Knee.

Detailed description

The study comprises a 14-day Screening Period, a 22-week Double-blind Treatment Period, and a 30-week Open-label Treatment Period, with an additional 4-week Follow-up Visit. Subjects will be randomized into a low-dose or high-dose group receiving either active or placebo treatment during the DB period. The WOMAC version 3.1 using the NRS will be used for the primary and secondary efficacy endpoints. Safety assessments will include assessment of AEs, vital signs (blood pressure, respiratory rate, pulse rate, and oral temperature), clinical laboratory tests, physical examination, skin irritation, and electrocardiograms (ECGs).

Conditions

• Pain Associated With Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	X0002	Subjects will complete 22 weeks of double-blind treatment and then enter into 30 weeks open-label treatment.

Timeline

• Start date: 2021-09-24
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2017-03-16
• Last updated: 2024-03-28

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated drug study